跳至主要内容
临床试验/CTRI/2025/09/094680
CTRI/2025/09/094680尚未招募不适用

COMPARISON OF OLP (OROPHARYNGEAL LEAK PRESSURE) AND PERFORMANCE CHARACTERISTICS OF I-GEL AND BASKA MASK IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY UNDER GENERAL ANAESTHESIA

GMERS HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
DIFFERENCE OF OLP IN IGEL AND BASKA MASK AFTER INSERTION IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY SURGERY

研究概览

简要总结

the study is being conducted to compare the effectiveness of two suoraglottic airway devices,the baska mask and the igel,in adult patients undergoing elective laparoscopic appendicectomy under general anaesthesia.the main aim is to rpvides better seal,measured by oropharyngeal leak pressure,and to assess their clinical performance.

after approval from the institutional human ethics committee,written informed consent will be obtained from eligible patients aged 18-60 years,with ASA  1 and 2 and BMI 19-30 kg/m2.particioants will be randomly allocated to either the baska mask group or the i gel group using envelope method.

all patients will undergo standard preanaesthetic assessment and fasting protocols.intraoperative monitoring will include ecg,non invasive blood pressure,pulse oximetry and capnography.patient induced with routine GA protocols.then igel or baska mask inserted and correct placement will be confirmed by b/l air entry checked and capnograph show square wave.and oropharyngeal leak pressure measure at 1 mins,5 mins and after creating pneumoperitonium.by taking spontenous ventilation,pressure adjusted valve closed up to 40 and then monitored plateu pressure.the value of plateu pressure > 10 sec consider as orophryngeal leak pressure.

a total 50 patients (25 each group) will be recruited based on sample size calculation for adaquate statistical power.this propspective randomised,open label study will be conducted in department of anaesthesiology,GMERS gotri,vadodara,over a period of one year.

the primary outcome is oropharyngeal leak pressure.secondary outcomes includes first attempt success rate,number of attempts,insertion time,need for airway manipulations,post operative any complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA GRADE 1 AND 2, BMI MORE THAN 19 AND LESS THAN 30 MOUTH OPENING MORE THAN OR EQUAL TO 2.5 FINGERS PATIENT IS WILLING TO PARTICIPATE AND GIVE CONSENT.

排除标准

  • PATEINT WHO DID NOT COMPLY TO MINIMUM 8 HOURS OF FASTING,WITH DIFFICULT AIRWAY,WITH ACTIVE UPPER RESPIRATORY TRACT INFECTION,WITH HIGH RISK OF ASPIRATION.

结局指标

主要结局

DIFFERENCE OF OLP IN IGEL AND BASKA MASK AFTER INSERTION IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY SURGERY

时间窗: DIFFERENCE OF OLP IN IGEL AND BASKA MASK MEASURE AT 1 MIN,5 MIN AFTER INSERTION AND AFTER CREATIMG A PNEUMOPERITONEUM

次要结局

  • 1. ASSESMENT OF FIRST ATTEMPT SUCCESS RATE(2.NUMBER OF ATTEMPTS)

研究者

发起方
GMERS HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SHAH ZALAK SHEETALKUMAR

GMERS medical college and hospital

研究点 (1)

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